OpenRegulatory

OpenRegulatory provides a range of services designed to assist medical device startups in navigating the complexities of regulatory compliance. The company offers a Regulatory Strategy Workshop that helps startups establish a clear regulatory path before product development begins. Additionally, OpenRegulatory has developed a comprehensive program called Headstart, which includes educational videos, document reviews, weekly meetings, and regulatory software to efficiently bring medical devices to market. The company’s proprietary software, Formwork, is specifically designed to simplify and automate the compliance process. OpenRegulatory also offers document review services to advise on potential audit findings and improve documentation efficiency. They conduct internal audits in compliance with ISO 13485, including preparation and audit report writing. For more specialized needs, OpenRegulatory provides custom regulatory support, such as writing documentation, addressing audit findings, closing CAPAs, and filling interim regulatory roles. The company also offers services for acting as the Person Responsible for Regulatory Compliance (PRRC) under MDR and serves as a Data Protection Officer (DPO) for companies processing personal health data under GDPR. OpenRegulatory operates on a four-day workweek, promoting a balanced work environment, and maintains a bootstrapped, profitable business model focused on delivering value to healthcare startups.